Pfizer

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache

12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Received the first dose of vaccine, no problems for 12 hours, then I started to have non-stop shivering and fevers for almost 18 hours then felt better.

Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.

Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21

nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.

Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.

19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -

30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.

Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.

Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.

12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.

APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP

chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.

Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.

17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN

fatigue, chills started about 8 hours after the vaccine; went to bed early and by 24 hrs the reactions had gone away. No pain at the injection site.

Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed while applying my deodorant for the day). Swelling was the size of large lemon. Smaller amount of swelling noticed in right armpit, also. Vaccinations had both been done in my LEFT arm and greater swelling was in left armpit. Had fever, chills and headache this same day requiring me to take round the clock doses of Tylenol. By the following day, fever and chills were gone but swelling of armpit still present. Swelling is slowly diminishing but still present by day 3, as I send this notification.

COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.

Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.

Had shot at 11am on Fri. 1/8. Woke up at 230 am Sat. morning 1/9 with chills, fever 101, aches, headache and fatigue. Started to feel better later in the day, but still had fever 100, bad headache and very fatigued. Still had fever at bedtime at 830 of 100.2. Woke up at 430 am for work on Sunday 1/10 feeling better and no fever. I was still somewhat tired but that was it. Nothing since this writing.

four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls

Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.

Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.

Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient) reported for herself. A 60-years-old female patient received first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in left arm, on 05Jan2021 13:00 at single dose for COVID-19 immunization. Reason why batch/lot is unknown was misplaced/discarded. The patient was not pregnant at the time of vaccination. Medical history included known allergies: Penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced fever, chills, headache, fatigue on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the events was recovering. Since the vaccination, patient hasn't been tested for COVID-19. No follow-up attempts are possible, information about lot/batch cannot be obtained.

developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.

About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and extreme fatigue. I slept off and all day and at 3:00 am 1/13/2021 I woke up and felt much better. chills, headache and body aches all gone. Some fatigue still lingers. I did not have fever at any time.. My arm injection site was less sore than the first vaccine.

achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.

Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.

Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.

flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.

Within 15 min of admin; pt reported feeling super drowsy and complained of Headache. She was given water and Acetaminophen, 25mg of Diphenhydramine. BP 140/64 Pulse 74

Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.

I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.

I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.

SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH

6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE

fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.

Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.

Metallic taste in mouth, tingling of sides of tongue, dry throat/unable to clear throat. Resolved within 1 hour of injection.

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.

received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.

1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums

chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate. The patient previously took COMPAZINE and BACTRIM DS and experienced allergies. The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F. On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

chills; headache; fatigue; fever 101; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in right arm on 09Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included hypothyroidismand arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), progesterone and estradiol (DOTTI). The patient previously took ace inhibitors and experienced allergies. The patient had first dose of BNT162B2, via unspecified route of administration on 18Dec2020 11:00 AM, lot number: EK507, in right arm at single dose for COVID-19 immunization. On 09Jan2021 2:30 AM, the patient woke up and experienced chills, fever 101, headache, fatigue and body aches and it lasted most of the day. The patient went back to bed at 8:30 PM and still had fever 100.2 and fatigue but most other symptoms getting better. The patient woke on 10Jan2021 at 4:30 am for work, no fever and some fatigue but that was it. No other reactions since this writing. The outcome of the event fever was recovered on 10Jan2021 and the outcome of the remaining events was recovering. No treatment was given for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressure 8/10 and appeared ashen and diaphoretic. Paramedics from the vaccine facility immediately responded to the patient. Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things". Patient carried an epi pen but stated she usually went to the ER and was treated there. On-site paramedics gave 0.5 mg IM to Left deltoid. Patient stated chest pressure went down to a 3/10, and she felt better. Ambulance arrived and patient was transported to Hospital.

Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare professional (patient herself). A 60-year-old female patient received the second dose of bnt162b2 (lot number: Ek9231), intramuscularly on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient was not pregnant. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (lot number: Ek5730) intramuscularly on the right arm on 22Dec2020 at 08:00 AM. On 11Jan2021 14:00, the patient became very sleepy four hours after second dose. The patient was recovering from the event. No treatment was given in response to very sleepy 4 hours after second dose.

right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort

Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.

Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.

I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, and was instructed to wait in observation area for 30 minutes. At 1650 patient reported that her tongue and back of throat were beginning to itch. No other symptoms. No difficulty breathing. Vital signs stable. Symptoms persisted, so decision was made to send patient to hospital emergency department. Patient did not want emergency transport, and was stable, and husband transported to hospital in POV. Onsite and hospital care team agreed to this plan. RN escorted patient from clinic to car. Patient and husband knew how to use EpiPen and drove directly to nearby ED for observation.

increased postnasal drip; had a fever of 100.7 orally; bodyaches; headache; chills; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient (not pregnant) received the second dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 09Jan2021 09:30 at single dose in right arm for COVID-19 immunization. Medical history included asthma, hypertension/ Blood pressure, acid reflux, food allergies, Known allergies: tree nuts, peanut, shell fish, Penicillin, Erythromycin, IVP dye, Rocephin. The patient's concomitant medications in two weeks included Blood pressure, acid reflux. The patient previously took the first dose of bnt162b2 on 19Dec2020 for COVID-19 immunization and experienced Sore arm. No other-vaccine-in-four weeks. Second dose on 09Jan2021 within 17 hours had a fever of 100.7 orally, body aches, headache, chills and increased postnasal drip on 10Jan2021 02:30. No treatment received. No covid-prior-vaccination and no covid tested post vaccination. The outcome of the events was recovering.

Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.

Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough

Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.

horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a contactable other health professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 12Jan2021 11:15 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin and COVID. The patient had COVID prior to vaccination. Concomitant medications included lisinopril and escitalopram; these are the other medications the patient received in two weeks. The patient previously took betadine and experienced allergies. On 13Jan2021 02:30 AM (as reported), the patient experienced a horrible headache, felt really bad, 102 fever, achy, and fatigued. The patient woke up at about 2:30 am and had a horrible headache. Got out of bed at 4:30 and felt really bad. She had 102 fever. She was still running 100 at 5:42 pm. She was achy, still have a headache and am very fatigued at the time of report. She asked if she can take something for the fever and headache. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered. Information on the Lot/Batch number has been requested.

Very tired; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient experienced very tired on 12Jan2021 with outcome of recovering. Information on the lot/batch number has been requested.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

body aches; major headache all night long, all over her head. It was a pressure headache; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899), via an unspecified route of administration in the right deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history included wolff-parkinson-white syndrome (WPW syndrome) from 2000, heart surgery from 2000, and allergic to sulfa with hives. Mother is diabetic and sister is prediabetic. There were no concomitant medications. On an unspecified date, she experienced body aches. She took paracetamol (TYLENOL). She also had major headache all night long, all over her head. It was a pressure headache. Someone gave her ibuprofen (MOTRIN) and within 3 hours she was totally fine. Outcome of the body aches was unknown and of the headache was recovered on an unspecified date.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.

Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest tightness, itching throat, and headache,

C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.

Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.

Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.

After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.

itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.

Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.

FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.

Headache, cold chills, body ache started about 10:00am on 1/29/2021. It is now 1/30/2021 @ 7:56pm and still have a headache and feel tired as have been all day.

Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.

Headache from approximately 1300 to 2000. I took naproxen at 1600 which did not help headache. Fell asleep at 2000. Headache gone next morning.

nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min later) Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted. Wed 1/27/21 7pm exhausted, foggy Thurs 1/28/21 5am exhausted, foggy, no reserve Fri 1/29/21 5am tired, foggy Sat 1/30/21 Much better.

Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.

FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS

headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.

Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.

Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97. I called my employer and had COVID test on 1-2-21 negative. Employer instructed me to go to get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.

Prolonged HA starting after receiving Pfizer COVID-19 vaccine on 29 Dec 2020-over 2 weeks. No fever/nausea/vomiting/photophobia/visual disturbances. Felt like a constant "vice grip". Not relieved with NSAIDS. Has a history of occasional migraines, but this HA presenting very differently. Resolved after 2 weeks. She did receive dose 2 on 1/19/2020 without recurrence of HA or ant concerning side effects.

Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!

I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.

Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.

chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.

I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.

light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.

11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.

After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache

Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.

One hour after receiving the shot I was extremely exhausted. Slept for 5 hours. Woke up with 99.8. Felt like I had been drugged. Next day felt groggy with headache.

High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.

injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.

high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.

Severe headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3249), via an unspecified route of administration on 14Jan2021 05:15 at single dose on left arm for COVID-19 immunisation. Medical history included diabetes. Patient had no known allergies to medications, food, or other products. The patient's concomitant medications included metformin. The patient experienced severe headache on 14Jan2021 with outcome of unknown. No treatment was received for the event. Since the vaccination, the patient had been tested for COVID-19 on 14Jan2021 with unknown result. This case was reported as non-serious.

Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Have had same symptoms as COVID but much worse after 2nd shot. Symptoms started Day 4 after vaccine and continue today. Running fever for 5 days now. Still sick. Flu test was negative although I doubted it was anything else since I rarely get sick and when I do it only lasts a day or two. Will have a few hours where I finally think I am getting better and then another wave hits.

Sinus headache; Can feel the sinuses draining; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus issues from the past couple of days from an unknown date. Concomitant medications were not reported. It was reported that the patient woke up with a sinus headache, but as the day went on, it's gotten worse and she can feel the sinuses draining. She reported she got the 1st dose of the COVID-19 vaccine at the morning of the report. Outcome of the events was unknown. Information on the batch/lot number has been requested.

Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.

12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

Tested Positive on day 19 after the 2nd dose. Case starting having symptoms early Sunday morning with a really bad headache and sinus pressure. Now has cough and fatigue. Headache is starting to get better. Cough and congestion is not.

left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.

fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.

02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.

on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021

On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.

pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.

Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

About 4 hours after my administered 2nd dose I experienced severe pain in my TMJ mostly on the left but milder on the right. That developed into a bad headache but was relieved with 200mg Motrin in the evening. The following day I experienced flu-like symptoms, chills (I did not take my temperature), muscle joints, fatigue, continued headache and milder pain in my bilateral TMJ. I continue to take Motrin every few hours. I did not experience the TMJ pain with my first dose in January 2021 but I did have mild flushing, flu-like symptoms. I thought I would report this as I have bilateral TMJ implants since 1997.

Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety

The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.

2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.

Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021

Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation

I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today

2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up

Approximately 4 hours after injection, I developed a severe, one sided headache. Extreme fatigue developed the following morning, headache less severe. Extreme fatigue continued for 6 days, headache for 5 days. OTC analgesic was not helpful.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.

slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.

Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.

At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die

That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads

Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.

SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS

Pt experienced blurry vision to both eyes and slight headache. Onset approximately 25 minutes after receiving vaccination. Pt did not lose LOC, did not lose vision completely. No problems with gait. Alert and oriented. Episode was transient and all sx's went away after about 30 minutes. After sx's resolved, pt refused transport to hospital for further evaluation, signing CFD refusal form stating able to drive self home.

Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.

continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.

5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.

Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.

At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.

SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL

4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep

I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.

Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"

Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER

Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.

Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.

I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.

Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.

Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on BP medication. I have been taking medication for 2 weeks and my BP has maintained high

acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol

Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.

Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.

1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.

My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.

Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021

Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibuprofen and went back to sleep. When I woke up later I felt better but was tired and achy for the next 24 hours. I continued taking Ibuprofen So adverse event lasted approximately 48 hours

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Extreme fatigue from 1620 on 1/6 gone when arose at 730 on 1/7 Fever starting at approximately 1900. Fever broke in the early am approximately 0300 awoke and noted wetness as if had been sweating No fever when arose

Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.

Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)

INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021

red rash around injection site soreness at injection site had bump on injection site body aches headache

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.

15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.

experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.

Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.

12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

03/15/21 @3:30AM awoke with significant headache and vertigo, room spinning around me, could not lay flat. By about 7:00AM vertigo stopped, had HA, dizziness with loss of balance. Ibuprofen 400mg q3-4 hrs, sudafed 30mg q4 hrs. Continued unchanged x 48 hrs. Today, 03/17/21, HA, dizziness, loss of balance somewhat improved, still taking ibuprofen 400mg every 4-5 hrs . Had covid in January 2021 with HA and vertigo as presenting symptoms.

Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.

A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.

Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.

/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.

After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.

Mild aches and chills. Temp 100.4 for part of the day. Symptoms started about 7AM and chills and aches were over by 4-5 PM. Temp was 99:4 at bedtime and normal this morning and feel fine today. Only reactive symptoms after 2nd vaccine.

I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting

Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient). A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at 14:15 as a single dose, for COVID-19 immunization. Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks. On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was given for the events. Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

At approximately 2:00 AM I woke up with body aches, a very bad headache, and chills. These symptoms continued for the next twelve (12) hours and disrupted my ability to function normally.

Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working. I am a physician doing telemedicine

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.

Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.

nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)

Chills, body aches and low-grade fever. Took 1-Tylenol 500 mg and 2-200 mg Ibuprofen. After 6 hours fever was gone and feeling better.

Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.

COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

Extreme fatigue starting next morning Saturday after vaccine. Slept almost continuously until Sunday afternoon.

After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21

Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell

Fever ~ 101F, started about 18 hours after injection, lasted about 8 hours Headache, started with fever, lasted about 12 hours

3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'

03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.

Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.

Complained of itchy throat and trouble clearing throat. BP 186/98, p140, O2 sat-97% Denies shortness of breath, no dyspnea, no trouble swallowing, no hives or rash. Did not bring her Albuterol with her Repeat BP in 5 minutes- 154/85, p-127, O2 sat-97% Evaluated by Dr. 1343: given Zyrtec 10 mg sublingual, 13:50 pm BP- 146/92, p-118, O2 sat- 97% states decreasing symptoms, no need to clear throat, slight itchiness in throat. denies shortness of breath, no dyspnea, no trouble swallowing, 1400- discharged home with instructions to use inhaler, call 911 or seek immediate care if symptoms return or worsen in any way She will take Claritin or Zyrtec prior to second shot and will also bring Albuterol

Patient reported symptoms on Sunday the 14th with a headache, cough, cold symptoms, sinus congestion, stuffy nose, and drainage. Patient is still congested, but other symptoms resolved. On 3/17/21 - Patient was tested and results were given to her on the 18th showing she was positive for Covid19.

March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest

I started feeling fatigued about 3 hours after vaccination. By evening I felt sickly (How you might feel at the onset of a cold) and I started getting a bad headache. The headache lasted for 48 hours. It was severe and I had to stay in bed. I am just now starting to feel a little. better

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days

Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.

20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours.

Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.

I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.

Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.

Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).

Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.

neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

pt reports having sharp pains in the head lasting about ten seconds, and then going away before receiving the vaccine. but the frequency has increased since getting the vaccine

After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.

Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.

Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away

Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills subsided in 4 hours, muscle aches in 6 hours.

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without incident and went to the observation area. The VR was then sitting with his wife when he "was thinking of the vaccine" and he became unresponsive. I was called to the site. The VR was pale, cool, and diaphoretic. The VR became responsive and was assisted to the cot where he laid flat. The VR's wife states that this is typical behavior and response for him. An ambulance was called by the paramedics that were on scene in the observation area. The VR refused transport. The VR was given water and candy and was able to ambulate without difficulty. VR remained in the observation area for 40 minutes and then discharg

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire next day along with fatigue. Today, March 27th, I have woken up feeling better, no fever.

Approx 8 hours after the first vaccine shot, I felt like I had mild flu like symptoms without a fever: body aches, and headache

100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat nausea aches cough Continue with very sore throat, fatigue nausea congestion dry cough nasal congestion

At 20 hours after vaccine, experienced chills, extreme fatigue, headache, fever fluctuations between 97.1 and 104.3 degrees for about 24 hours

Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness

Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness

The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it came back two days later positive for covid. 24 hours after 3nd vaccine. Also have pain in left breast Under arm where shot was given

she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting sick; got the chills; This is a spontaneous report from a contactable consumer (also mentioned being a Physical Therapist Assistant). A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EN6203, Expiry Date: Jun2021, in Pharmacy/Drug Store, via an unspecified route of administration, in left arm on 26Feb2021 at 12:00, at 60 years of age, as single dose for COVID-19 immunization. Medical history included SARS-CoV-2 test positive in Nov2020 (COVID-19 Virus throat swab test was used), also reported as COVID-19 infection in Nov2020 with no symptoms, except a slight sore throat and gingival disorder from an unknown date. On 26Feb2021 the patient had no symptom, saying she felt great. She reported she worked out and was in great shape for her age. She said she was not the typical 60 year old. On 09Mar2021 in the evening the patient felt like she was getting sick and got the chills and she had never had that happen before, and didn't know if her symptoms were from the 2 pills of an herbal supplement she used for periodontal issues to strengthen her gums she had ordered online (she never saw the product in a store) and that she had taken on the same day; moreover she tested positive for SARS-CoV-2 infection on 11Mar2021 with a COVID-19 Virus 24-hour nasal swab test done at her work. The events didn't require visit to Emergency Room or Physician Office. It was reported that the patient was scheduled to receive her second dose of vaccine 19Mar2021 and the patient wanted to know if this is possible with her current diagnosis and how likely it is this is a false positive test for SARS-CoV-2. No treatment was administered for the reported events. At the time of the report the outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.

Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.

Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.

Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.

Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.

One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.

I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue. I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow. Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision. Had second vaccine on 3/31/21 and eye seemed to get worse. Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse. Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA). I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis. Received results from biopsy on 4/13/21 and negative for GCA. Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified. Optic nerve is still swollen and vision impacted. I am to return to clinic in 8 weeks and see if improvement. I have never had any issue like this in the past.

Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%. 4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!

4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.

I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Exhaustion; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) as SINGLE DOSE in left arm, dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:45 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, joint stiffness, back pain, arthralgia and unknown date, Allergic to insect stings. Concomitant medication included acetylsalicylic acid (ASPIRIN); paracetamol (TYLENOL). The patient previously took Augmentin and experienced drug allergy. On 16Feb2021 the patient experienced both times like mini version of covid which patient had a year ago. now right side of my neck hurts and still inflamed, feeling extremely fatigued, headaches, exhaustion (suspected covid-19) The outcome of both times like mini version of covid which I had a year ago, now right side of my neck hurts and still inflamed, feeling extremely fatigued. Headaches, exhaustion was not recovered.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) to reported events is probable.

She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of fullness in ears and lymph nodes; sense of fullness in ears and lymph nodes; I feel pretty awful after this first dose.; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 17:40 (Batch/Lot Number: EL9269) as single dose at the age of 60-year-old for COVID-19 immunisation, offered at the health system she works for and administered at hospital. Medical history included ongoing acoustic neuroma on 8th cranial nerve left side, on the side she felt the intense ear pain, diagnosed 2007-2008, thyroid cancer from 2004 and thyroid removed, her hormone levels are normal, COVID-19 in Dec2020. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient experienced I feel pretty awful in Feb2021 with outcome of unknown, ear pain on 03Feb2021 with outcome of not recovered, sense of fullness in ears and lymph nodes on 03Feb2021 with outcome of recovered on 05Feb2021, body aches on 04Feb2021 with outcome of not recovered, headache on 04Feb2021 with outcome of recovering, sleepiness on 04Feb2021 with outcome of not recovered, fatigue on 04Feb2021 with outcome of not recovered, chills on 04Feb2021 with outcome of not recovered, body temperature: 97.5-98.7 on 04Feb2021 with outcome of unknown. The events did not require a visit to Emergency Room or Physician Office. The course of events was as follows: Patient expected that since she just had COVID in Dec2020, she thought her response to the vaccine would not be severe because she already had some immunity from the infection. The evening of the vaccine, on 03Feb2021, she experienced ear pain and a sense of fullness in her ears and lymph nodes. The ear pain was almost immediate after vaccination. On 04Feb2021, the next day, she woke up with a headache. It was an unusual headache. It did not go away with Tylenol. Then about halfway through the day, she developed significant body aches like when she had COVID. She also experienced extreme sleepiness like when she had COVID too. She took Motrin and had to lie down during her work day. The Motrin did help. Then mid morning 04Feb2021, she got a chill. She couldn't get warm enough. She had no fever. She checked multiple times. Her temps ranged from 97.5-98.7 on 04Feb2021. She experienced fatigue. She did not know the seriousness for any of the side effects she experienced. As of 05Feb2021, her headache has improved. She was still experiencing sleepiness and fatigue. The chills she developed mid day. She had not them right now. She has better and worse moments just like when she had COVID. She was worried about the second one. The patient underwent lab tests and procedures which included body temperature: 97.5-98.7 on 04Feb2021, COVID-19: positive in Dec2020. No other relevant tests. Therapeutic measures were taken as a result of headache and sleepiness. A Product Complaint was filed.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist

My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.

Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.

congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu

VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .

Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.

Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.

aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.

Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.

couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6

worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.

Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.

Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.

Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.

Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.

Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.

Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.

patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

Sunday 1/10/2021 at 10:30 am started with chilling then body aches and headache started in the next hour then headache. Chilling better about one hour later. Took ibuprofen at 1:15 pm and relief of aches and headaches in about 30-60 minutes. Had dry cough. Very tired all day.

1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)

injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.

Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose

On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning 01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.

30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for observation

Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.

fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.

congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient). A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15 at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing. The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

Employee reported a fever of 101.1 and fatigue post 24 hours after second covid vaccination. Was resolved by the next morning with a temp of 96.8.

Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.

Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.

Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.

Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.

At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.

Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today

Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.

chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.

Received Covid vaccine on 01/12/21. Late that afternoon, developed fever, chills, headache, body aches, and fatigue, lasted throughout the day on 01/13/21.

Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.

Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.

but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.

"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.

Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.

i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.

12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. This was only partially mitigated by acetaminophen and ibuprofen. It lasted until about 42 hours post vaccine.

Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and co-worker). This is the first of two reports. A 61-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: unknown), intramuscular, on 06Jan2021 13:30 at a single dose on left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was also reported that she received the vaccine at a military facility. There were no additional vaccines administered on same date of bnt162b2. Medical history included high blood pressure diagnosed about a month ago (Dec2020) and ongoing, and glaucoma from an unspecified date (diagnosed when she was 15 years old) and ongoing. Concomitant medications included losartan (Manufacturer: Lupin, 50 mg tablet) for high blood pressure, venlafaxine ER (Manufacturer: Aurobindo, 150 mg Prolonged-release capsule) as anti-depressant, latanoprost (Manufacturer: Sandoz, 0.005 %) for glaucoma, and brimonidine tartrate, timolol maleate (COMBIGAN, Manufacturer: Allergan) for glaucoma; all were from unspecified dates and ongoing. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9699), intramuscular, on 19Dec2020 at a single dose on left arm for COVID-19 immunization; there was no adverse event following this vaccination. The patient experienced headache on 06Jan2021 at 11:45 am (As reported, pending clarification). The patient reported that she did not have anything with the first dose. She got the second dose of the Pfizer Covid Vaccine on 06Jan2021 at 13:30. She started getting headache at 11:45 am (as reported) but she didn't think much of it. On 07Jan2021, she had a headache and she took two Tylenol and then went to sleep. She woke up around midnight that night and her headache got a little bit worse, so she took two Tylenol again and fell asleep. In the morning of 08Jan2021, around 2:30 am her headache got worse and worse, and she took three Tylenol. Her headache was still there but it was not enough to go to the emergency room or anything. She panicked on Thursday (07Jan2021) since her headache was still there; her headache was still lingering but it was going away. Her headache pain was at 7 out of 10 on an unspecified date. She stated that she was supposed to work at the time of report, but she called out of work due to her headache. Therapeutic measures were taken as a result of the headache and included treatment with Tylenol 500 mg (lot number: DFE3060A, expiration date: Apr2022). The adverse event did not require a visit to Emergency Room or Physician office. Outcome of the event was recovering.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.

Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.

itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.

DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19

Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.

24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.

Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.

Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable after 15 hours of the vaccine Chills- off and on after about 15 hours of vaccine Body aches and pains/ fatigue Headache- severe

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.

Around 7:30 PM I arrived home from work and started feeling very lethargic, extremely tired. Around 3 AM I started running a temperature (100.5F) and started with the chills and body aches. I still feel very tired.

Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.

Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs

The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.

sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

received 2nd pfiser covid vaccine and had body aches, tiredness and headache for 36 hours. started 12 hours after vaccine

Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran

Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic

SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENOL Q 4 H

Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion

Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.

Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.

not sure if it is covid; feeling unwell; headache; dizzy; sleep the whole day/ falling asleep; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as Pfizer Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 04Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose of the Covid vaccine on 04Jan2021. She stated that the first day it was okay but on the second day, she slept the whole day and even when standing up cooking, she was falling asleep and on the third day, she was completely okay. After that day, she was okay until now. She was now feeling unwell, headache (she never gets a headache like this before, a really, really headache) and dizzy (all starting yesterday). She takes Tylenol and will be okay for 8 hours. She further reported that she did not have a fever. She added that on Sunday, she was dizzy and has an on and off headache but not all the time and also for today too. She is not sure if this is a side effect or if it is covid. She inquired if these are side effects or does she need a Covid testing. The outcome of the events was unknown. The following information on the batch/lot number has been requested.

No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO

Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis. Patient was administered diphenhydramine 50 mg PO while in vaccine clinic, rapid response was called and patient was transported to the ED. Patient was administered famotidine 40 mg PO and prednisone 50 mg PO and released from ED 5 hrs later.

felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.

A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.

FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on

A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.

Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.

headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.

Severe headache 15 hours after getting second COVID vaccine. Relieved partially with acetaminophen. Dull headache second day. Headaches are very unusual for me.

Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.

This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.

Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.

Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.

(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.

Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium

very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.

Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.

lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.

sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.

Mild headache, scratchy throat, dry cough. BP 140's/80's, pulse 82, 100% O2 sat. Given Benadryl 50 mg.

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient

Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.

Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)

61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines

12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.

I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.

Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling

Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.

sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.

Symptoms - ? Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in Medical Directive and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.

Symptoms - ?Patient reports at approximately 02:00 she woke up with body aches, chills and fever (Tmax 102.1), Tylenol taken at 05:00, at time of call temp 101. Patient denies COVID-19 exposure without proper PPE and denies travel. Patient next scheduled to work tmw morning. Last day of work and shift - ?Tuesday (2/2) Home remedies? - Tylenol at 05:00 Any improvement? - mild Recommendation? Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in the paperwork and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.

had been running a temperature of 99.5 to 101; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female non-pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 3249 and expiry date unknown) via unspecified route of administration at the left arm on 11Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient has no covid prior vaccination. Concomitant medication included losartan and vitamin; both from unspecified date for unspecified indication. The patient previously took vancomycin and Keftab; both experienced allergies. The patient had no other vaccine in four weeks. The patient had been running a temperature of 99.5 to 101 since Monday 11Jan2021 during the night (also reported as 11Jan2021 12:00 AM). The patient was not covid tested post vaccination. The patient did not receive treatment due to the event. The outcome of the event had been running a temperature of 99.5 to 101 was not recovered.

Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. The symptoms lasted a day and resolved.

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.

She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.

Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.

On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired

I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.

splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.

Headache began immediately after vaccine administration, B/P 180/118, Denies chest pain, SOB, pruritus, rash, blurred vision, recommended transport by EMS but patient declined

30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

On Thursday,1/21, I felt fine and was working. At 1530, I began having rigors and SOB and called 911. At the ED my temp was 103.

Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.

2nd COVID-19 vaccination on 02-11-2021. NO symptoms with 1st vaccination. I woke up to a fever of 99.8 on 02-12-2021, which gradually escalated to 102 within 2 hours. It remained at 102 for most of day. Finally came down to 101.1 by around 6:00PM. My normal body temperature is low- around 97.6. I also had an odd sensation at the back of my throat- cannot really describe it- sometimes hurt to swallow- but not consistently. Only felt that symptom the day of 02-12-2021. The next morning, my temperature was 99.2. Eventually returning to normal around 3:00 PM that afternoon. I did not take any OTC medications during the course of recovery.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.

I received my first dose at 9:50am on February 3, 2021. Approximately 15 minutes after the first vaccine dose was given (10:05am) I began to get an itchy throat along with an allergic type cough. The cough went away in about an hour but I still had the itchy throat off and on throughout the afternoon. I called my Primary Care provider and she recommended I take 25mg of Benadryl every 6 hours and to call 911 if my symptoms got worse. I took the recommended doses at 5:10pm and 11:15pm that day and all symptoms resolved. I had no symptoms the following day and did not take any Benadryl the following day. I would like to note that I was sent outside the building immediately after the vaccine to wait for the 15 minutes because they could only have 20 people in the room, so there was essentially no monitoring if my symptoms would have gotten worse. We drove to the ER and just sat in the parking lot to be sure the symptoms were not progressing. I am still waiting to see if it is recommended that I receive the second dose of the vaccine. At my provider's recommendation, I am seeing an allergist tomorrow to further discuss.

This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient (not pregnant, age at vaccination reported as 61-years-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left arm), on 02Feb2021, at single dose, for covid-19 immunization. Medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), for covid-19 immunization. The patient felt flu like symptoms the day after the second vaccination dose on 03Feb2021. Symptoms have resolved on the second day after vaccination. The patient recovered from the adverse event on 04Feb2021. No treatment was received for the adverse event. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.

Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.

Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy

Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.

2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.

patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.

Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.

Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.

Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.

Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pepto bismol today. Hope it helps. I am still not sure if these are due to the vaccine or not?

arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue. Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).

on 01/14.21, The patient had the chills and fatigue. On 1/17/21, The patient developed severe right ear pain and right sore throat. On 1/19/21, developed multiple painful sores on the right side of the hard palate. On 1/20/21, the ulcers in the month got worse. Started on Valtrex. On 1/24/21, the patient felt better but the pain and sore throat returned on the 1/26/21.

Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated

I woke and I felt exhausted - like I would have to resign from work that day - that's how exhausted I was. At 6:00 pm, I felt like I had energy. And from then on - I felt like my body had been reset - like I had more energy. (Until the second dose of the vaccine.)

Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021

pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.

Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professionals. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) at the age of 61 years, intramuscular on the left arm on 27Jan2021 16:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure, COVID-19 and allergies to quinolones. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced fever 102.1, chills and achy on 28Jan2021 08:00. The patient did not received any treatment for the events. The outcome of the events was not recovered.

mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash

As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.

First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.

Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.

Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.

Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.

Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours. Hip pain continues worsening with walking and standing over time. Hips started to ache after first vaccine but didn't realize it was attributed to vaccine. Started taking fish oil and Glucosamine tabs for joints. Hip pain after 2nd vaccine increased and continues today. Went to Internal Medicine clinic to be seen on 1/25/2021. Xrays, UA, ANA, CBC and CMP were done. Xrays show mild degenerative changes to hips bilaterally. ANA elevated at 2.1. Everything else within normal limits. Physician then added RA, C- Reactive Protein and Sedrate, all coming back WNL. Will be making appointment with Rheumatoidologist.

Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.

Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all the next day 02/28/21. Still had a slight headache on 03/01/21.

Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.

1.5 days after vaccine, lost sense of taste and most smells. I had a bad headache that day and slightly less on Saturday. I was told to get a covid test which I did Saturday morning. I received the results of negative on Sunday the 6th. Today is the 10th, one week after the vaccine, and still no taste. I met by phone with my Dr. , and she said to report it as a side effect to the vaccine.

Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event

Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is for reporting purposes only; no care needed; all side effects abated in a reasonable time period.

I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat. Exam was normal. Calm patient, clear lungs, strong pulse. No rash. Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.' I suspect anxiety. Given Benadryl and continued monitoring. All symptoms resolved. Observed total of 45 minutes and discharged home. Ok for next vaccine.

Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.

February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.

I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the morning of the 9th. My headache pain was an 8 out of 10 from March 9 to March 11 and remained super nauseous. I got some anti nauseous medicine from the doctor. On March 12, I woke-up perfectly well. This headache and nauseousness felt like my usual reaction to soybean ingestion. I normally have a delayed reaction when I ingest soy bean. Normally, if I ingest soybean, i react 7-12 hours later. I am positive that I did not have any soybean before or after my vaccination.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm, fever - 530pm-939pm , headache and extreme fatigue - all day and into the next day (3/7)

Shortly after receiving vaccine, patient began to experience shortness of breath and throat itching/tightness.

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and off for the first 2 days All of the above were relatively mild

Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.

Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping 15-18 hours per day)

8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction

9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3/15/2021 feeling better , just still feeling tired.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.

Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.

Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.

Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.

woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.

Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site). A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.

Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours and lasted 2 days.

1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.

fever; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at the age of 61 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported stopping medication on 10Feb2021 due to receiving COVID-19 vaccination on 12Feb2021 and then resuming therapy on 15Feb2021. Patient reported fever for 2 days after vaccination on 14Feb2021. The outcome of the event was unknown. Information about lot/batch number has been requested.

I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.

I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms. Everything hurts I am nauseous and exhausted my body feels really heavy

Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.

Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS stable all throughout, sat 100% the whole time. Called Dr., ordered to give Benadryl 25 mg po and Albuterol 2 puffs inhaler. Her symptoms got better, but continued. Called 911 since she's still coughing and continue to have the 'phleghm' like symptoms in her throat.' 911 assessed her and pt refused to go to ER for further treatment, she signed the paper. Sent her home with her husband, and instructed her to call 911 if her symptoms get worst.

Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation . Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.

Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.

Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache. Vaccine injection time 1715, symptom onset at 1720. Vitals: @1720: BP 148/94, HR 79, O2 98 @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom. Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room. Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER

Ears-ringing, and headaches started after about a week of second vaccine. Still occurring off and on 20 days after vaccine. Not continual and some days worse than others.

Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue continuing past that

Around noon the following day I started feeling achy and tired. My eyes burn and I have chills. Just feel like I'm coming down with something.

16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.

Fever, chills, headache, fatigue, body aches. Fever of 102.5 lasted for about 10 hours until I finally took Tylenol. My headache continued for about 24 hours. I felt like I had Covid all over again but in total it only lasted 24 hours.

Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol 325 mg caplets and headache was gone within a couple of hours. Also arm was quite sore first night but much better 2nd night.

Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.

COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,

On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.

Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.

Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.

started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.

Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.

minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician. A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI. The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.

Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home

On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.

Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days. Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives. Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.

Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

(1) Headache started shortly after injection, mild at first, then moderate, went away 48 hours later (2) Extreme fatigue started 4 hours after injection, improved somewhat 24 hours later, mostly gone 48 hours after injection (3) Tinnitus first noticed 8 hours after injection, mild or intermittent for the next 5 days, then became more noticeable and persistent; has been persistent and nonstop since then. (It has been one week since the injection.)

Had a sudden pounding headache & a super loud buzzing in my ears. The headache lessened & the ear buzzing went down a little bit, but ear buzzing is still pretty loud. The loud ear buzzing has not gotten any better 23 days later!!! My ears are still buzzing now. I am wondering will my 2nd dose of Pfizer Covid vaccine due on 04/01/2021 make my ear buzzing worse?

Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)

Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches. One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.

Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.

Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital. Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone. Took Zytec at home and slept. Symptoms were gone next day.

weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea

3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening

Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite

3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon